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RegisterSubject selected into study with BMI not as per protocol [Study Performance]
Hello
I like to share that if the BMI range in protocol was not follwed what shall be the impact.
As per protocol certain range has given as BMI for the study.
we do screening is general screening, on the the day of check-in we select the volunterrs based on medical screening record and protocol requirment.
Couple of subjects were selected into the study where the BMI range is not as per protocol.
What shall be the impact?
Can we proceed by raising protocol deviation or by a Note to file for the study.
Regards
Vivekanand
Edit: Category changed. [Helmut]
I like to share that if the BMI range in protocol was not follwed what shall be the impact.
As per protocol certain range has given as BMI for the study.
we do screening is general screening, on the the day of check-in we select the volunterrs based on medical screening record and protocol requirment.
Couple of subjects were selected into the study where the BMI range is not as per protocol.
What shall be the impact?
Can we proceed by raising protocol deviation or by a Note to file for the study.
Regards
Vivekanand
Edit: Category changed. [Helmut]
Complete thread:
- Subject selected into study with BMI not as per protocolvivekanand 2013-04-29 14:35
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Subject selected into study with BMI not as per protocol jag009 2013-04-29 15:17
- Subject selected into study with BMI not as per protocol Ohlbe 2013-04-29 16:45
- Protocol deviation Helmut 2013-04-29 15:20
- Protocol deviation Dr_Dan 2013-04-29 16:54
- Protocol deviation Helmut 2013-04-29 17:26
- Protocol deviation Dr_Dan 2013-04-29 16:54
- Subject selected into study with BMI not as per protocol sarada06884 2013-04-30 12:34
- Subject selected into study with BMI not as per protocol jag009 2013-04-29 15:17
Ing. Helmut Schütz